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Quality of Life Intervention for Patients Receiving Radiation Therapy for Advanced Cancer Treatment and Their Caregivers

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Mayo Clinic

Status

Completed

Conditions

Advanced Cancer
Quality of Life

Treatments

Other: Video-conference quality of life counseling
Behavioral: Quality of life counseling

Study type

Interventional

Funder types

Other

Identifiers

NCT03094780
15-009226

Details and patient eligibility

About

This study will use video technology in conjunction with in-person participation. This is a pilot project, where all enrolled participants will receive the multidisciplinary intervention. Participants (patients and caregivers) from Mayo Clinic Rochester will attend an in-person group session, and participants (patients and caregivers) from Mayo Clinic Florida or Northfield Mayo Clinic Radiation Oncology Center will participate through the use of video conferencing. The goals are to examine feasibility (percent of eligible patients and caregivers who enroll), attrition, and adherence (attend at least four of the six sessions), to determine any differences between the two formats, and to examine potential QOL differences as a result of the intervention.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 18 years of age.
  • Ability to attend all treatment sessions and follow-up.
  • Ability to provide written informed consent.
  • Ability to participate in all aspects of the study.
  • Initial diagnosis of cancer must have been 12 months prior to study entry.
  • Intermediate to poor prognosis, defined as an expected 5-year survival of 0%-50% in the judgment of the physicians entering the patient on the study.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1, or 2.
  • 1 week of planned cancer treatment (radiation or chemotherapy) at Mayo Clinic.
  • Has a caregiver also willing to participate.
  • Willingness to get e-mail/text reminder to complete the follow-up survey or complete the follow-up survey with a study coordinator by phone.

Exclusion criteria

  • Expected survival of <6 months.
  • Active substance abuse (alcohol or drug).
  • Participation in other psycho-social research trials.
  • Active untreated thought disorder (bipolar illness, schizophrenia, etc.).
  • Untreated suicidal intent or plan.
  • In need of psychiatric hospitalization.
  • Recurrent disease after disease-free interval of >6 months.
  • Previous cancer 5 years (except non-melanoma skin cancer and/or second cancer diagnosed at approximately the same time as this cancer).
  • Use of Proton Beam Radiation.

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Quality of Life Counseling
Other group
Treatment:
Other: Video-conference quality of life counseling
Behavioral: Quality of life counseling

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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